Tuberculosis evaluation

The accepted indications for delayed hypersensitivity skin testing include evaluation of immune disorders or chronic diseases that cause cellular immune dysfunction (e.g., uremia, cancer, AIDS, etc), exposure to infectious pathogens (e.g., Mycobacterium tuberculosis), evaluation of nutritional status (because malnutrition can result in cell-mediated immune deficiency), and in some cases, assessment of immune senescence. 

Design, evaluate, and assess appropriate regimens for the treatment of latent tuberculosis infection (LTBI) in all patient populations. 

Evaluate patients for latent tuberculosis infection with a tuberculin skin test. Initiate treatment of latent tuberculosis infection prior to therapy with infliximab. 

Serious life-threatening infections, including sepsis and pneumonia, have been reported with the use of TNF inhibitors. Patients should be evaluated for tuberculosisrisk factors and tested for latent tuberculosis infection prior to starting therapy. Concurrent use with other immunosuppressive therapy should be avoided. In clinical trials of all TNF-blocking agents more cases of lymphoma were observed compared with control patients. Patients with a prior history of prolonged phototherapy treatment should be monitored for nonmelanoma skin cancers. 

Cooksey RC, Holloway BP, Oldenburg MC, Listenbee S, Miller CW. Evaluation of the invader assay, a linear signal amplification method, for identification of mutations associated with resistance to rifampin and isoniazid in Mycobacterium tuberculosis. Antimicrob Agents Chemother 2000 44(5) 1296-1301. 

The technique of randomization was pioneered in the field of agriculture (plants too show considerable individual variation) by Sir Ronald Fisher, a visionary statistician. It is generally acknowledged that the first randomized clinical trial, conducted in the 1940s, was a study evaluating the use of streptomycin in treating tuberculosis conducted by the (British) Medical Research Council Streptomycin in Tuberculosis Trials Committee. The results were published in the British Medical Journal in 1948. 

The purpose of this example is to demonstrate the efficacy of a silver composition of the present invention against the bacteria that cause tuberculosis. This example describes the procedures for evaluation of the present invention for tuberculocidal efficacy. The methodology is based on the Tuberculocidal Activity Test Method as accepted by the EPAon Dec. 11, 1985. [Refer to United States Environmental Protection Agency, 1986. Office of Pesticides and Toxic Substances. Data Call-In Notice for Tubercuolocidal Effectiveness Data for All Antimicrobial Pesticides with Tuberculocidal Claims. (Received Jun. 13, 1986). 

Materials. The silver composition of the present invention comprised 10 ppm silver in water. The silver composition was evaluated employing a liquid to liquid matrix against Mycobacterium bovis BCG (TMC 1028). This organism causes tuberculosis in animals and can cause tuberculosis in humans. It is used as a stand-in for M. tuberculosis, the major cause of human tuberculosis, as tests have shown it to have a similar susceptibility to M. tuberculosis. The test organism was exposed to the silver composition in duplicate at four exposure times and quantified using membrane filtration. 

Crude extracts prepared from different parts of Turkish T. baccata have also been evaluated for their antimycobacterial activity. A CHCI3 fraction of the heartwood and ethanol extract of the leaves exhibited a minimum inhibitory concentration value (MIC) against Mycobacterium tuberculosis H37Ra strain of 200 pg/mL [102]. 

Hiserodt, R.D., Franzblau, S.G. and Rosen, R.T. (1998) Isolation of 6-, 8-, and 10-gingerol from ginger rhizome by HPLC and preliminary evaluation of inhibition of Mycobacterium avium and Mycobacterium tuberculosis. Journal of Agricultural and Food Chemistry 46(7), 2504-2508. 

Tortoli E, Dionisio D, Fabbri C. Evaluation of moxifloxacin activity in vitro against Mycobacterium tuberculosis, including resistant and multidrug-resistant strains./. Chemother., 2004, 14, 334-336. 

Castagnolo D, Radi M, Dessi F et al (2009) Synthesis and biological evaluation of new enantiomerically pure azole derivatives as inhibitors of Mycobacterium tuberculosis. Bioorg Med Chem Lett 19 2203-2205... 

The daily dose of isoniazid is 5 mg/kg, with a maximum of 300 mg/day in adults with normal liver and kidney function. In children, 8-10 mg/kg/day is an appropriate dosage, with a maximum daily dose of 300 mg, since the metabohsm of isoniazid in children is rapid. Untoward effects of isoniazid as a single antituberculosis drug can be evaluated in preventive tuberculosis therapy, since curative regimens usually consist of multiple drugs. 

Note TNF blocking agents may lead to serious infections, lymphoma, or fatalities, particularly in patients receiving concomitant immunosuppressive therapy. Patients should be evaluated for latent tuberculosis prior to treatment with adalimumab. 

---